Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing (ANSRS)

January 4, 2012 updated by: University of Florida

A Randomized Controlled Trial of NMES vs. Traditional Dysphagia Therapy After Stroke

Neuromuscular Electrical stimulation (NMES) for swallowing has recently been proposed for the treatment of dysphagia post stroke and is clinically receiving favor as a treatment modality, in the absence of strong research support. This study aims to investigate the effect of NMES therapy for dysphagia upon recovery of swallowing function following stroke. The study will follow a pilot randomized controlled trial design. Fifty one patients admitted to a sub-acute rehabilitation facility will be clinically screened for dysphagia, and randomized into one of three groups, NMES, sham NMES or usual care -behavioral swallowing therapy arm. All patients will be treated for one hour per day for 3 weeks, and their progress and outcome will be monitored. The results will add to the preliminary data on the effectiveness of this form of swallowing treatment for patients following stroke, and has the potential to enable more efficient allocation of resources to post-acute rehabilitation and thus benefit afforded to stroke patients, and the community.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This pilot randomized controlled trial (N=51) includes stroke patients admitted to a sub-acute rehabilitation facility. Subjects will be clinically screened for dysphagia, and randomized into three groups, NMES, sham NMES or usual care -behavioral swallowing therapy arm. Following randomization, all subjects will undergo a video-x-ray (modified barium swallow) of swallowing to confirm the presence of oropharyngeal dysphagia and provide objective data about the nature and degree of dysphagia. All patients will be treated for one hour per day for 3 weeks, and their progress and outcome will be recorded. Participants will be independently evaluated by a blinded assessor at baseline, post treatment and at 3 months following treatment. The primary outcome will be improvement in clinical swallowing ability, oral intake level, and body weight. The results will add to the preliminary data on the effectiveness of this form of swallowing treatment for patients following stroke.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Siskin Hospital for Physical Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stroke identified by neurological and radiological examination
  • Oropharyngeal dysphagia as confirmed by clinical and radiological examination
  • No prior history of oropharyngeal dysphagia by patient and/or caregiver report
  • No previous head/neck surgery or trauma that may impact swallowing ability
  • No other/concomitant neurological disorders (e.g. Parkinson's disease) that would impact oropharyngeal swallowing ability. This does not include post-stroke deficits.
  • Physician and patient/family agreement to participate.

Exclusion Criteria:

  • Exposed to previous behavioral or NMES swallowing therapy within 6 months of admission
  • Presence of progressive neurological disorder, such as ALS; Parkinson's or other neurologic disorders within the last 6 months;
  • History of neurosurgery (either ablative or stimulatory), encephalitis or significant head trauma.
  • History of a significant medical condition such as heart, liver, or renal disease; history or evidence of malignancy within the past 5 years other than excised basal cell carcinoma.
  • Because of FDA Warnings, patients with cardiac demand pace makers will be excluded.
  • Patients with evidence of significant cognitive impairment or dementia as reflected in a Mini-Mental test less than 23 and/or a score of 50% or less on the comprehension quotient on the Western Aphasia Battery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Usual Care
Patients will receive behavioral swallowing therapy comprising combination's of treatment strategies / exercises chosen from an approved hierarchy. This formulation of treatment will be designed and applied by the treating clinician.The treatment will be provided daily for a one-hour over a consecutive 3-week period.
Behavioral: swallowing therapy
Standardized behavioral swallowing intervention
PLACEBO_COMPARATOR: sham NMES
Patients will receive behavioral swallowing therapy comprising combinations of treatment strategies / exercises chosen from an approved hierarchy with the addition of non stimulating electrodes. A faux NMES device will be utilized with an active current display and non stimulating electrodes. The treatment will be provided daily for a one-hour over a consecutive 3-week period.
Behavioral: swallowing therapy
Standardized behavioral swallowing intervention
EXPERIMENTAL: NMES therapy
Patients will receive a protocol of standardized behavioral swallowing intervention combined with NMES. This formulation of treatment will be prescribed from a standard protocol and will be applied daily for one-hour over a consecutive 3-week period.
Behavioral: swallowing therapy
Standardized behavioral swallowing intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: 3 weeks post treatment
Mann Assessment of Swallowing Ability (M.A.S.A)and Functional Oral Intake Scale (F.O.I.S) change, without significant weight loss or dysphagia-related complication
3 weeks post treatment
Full clinical response
Time Frame: 3 months post treatment
Mann Assessment of Swallowing Ability (M.A.S.A)and Functional Oral Intake Scale (F.O.I.S) change, without significant weight loss or dysphagia-related complication.
3 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery of pre-stroke diet
Time Frame: Baseline, 3 weeks (post treatment) and 3 months post
comparison of diet intake
Baseline, 3 weeks (post treatment) and 3 months post
Dysphagia-related medical complications
Time Frame: Baseline,3 weeks ( post treatment) and 3 months post
Occurance of chest infection, dehydration or significant weight loss
Baseline,3 weeks ( post treatment) and 3 months post
Biomechanic evaluation of swallowing function
Time Frame: Baseline and 3 weeks (post treatment)
Modified barium swallow measurement will be used to document changes in swallowing biomechanics associated with change in swallowing following treatment.
Baseline and 3 weeks (post treatment)
Functional stroke recovery
Time Frame: Baseline, 3 weeks (post treatment) and at 3-months post treatment
Modified Rankin Scale and the Modified Barthel Index will be used to measure functional stroke recovery.
Baseline, 3 weeks (post treatment) and at 3-months post treatment
Neurological status/Stroke severity
Time Frame: baseline, 3 weeks (post treatment) and at the 3-month post treatment
National Institutes of Health Stroke Scale will be used to measure neurological status change.
baseline, 3 weeks (post treatment) and at the 3-month post treatment
Patient perception of swallowing ability
Time Frame: baseline, 3 weeks (post treatment) and at 3-months post treatment
Using a visual analogue scale patients will indicate ability to swallow.
baseline, 3 weeks (post treatment) and at 3-months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Center for Medical Rehabilitation Research (NCMRR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (ESTIMATE)

January 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21HD054752 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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